FDA Publishes Perspective on Paclitaxel-Coated Devices in PAD

January 14, 2021—Andrew Farb, MD; Misti Malone, PhD; and William H. Maisel, MD, from the Office of Product Evaluation and Quality (OPEQ) at the FDA’s Center for Devices and Radiological Health, published a Perspective article on the latest findings of paclitaxel-coated devices (PCDs) for peripheral artery disease (PAD) in The New England Journal of Medicine (NEJM; 2021;384:99-101).

Dr. Farb is Chief Medical Officer of the OPEQ Office of Health Technology 2 (Cardiovascular Devices); Dr. Malone is Assistant Director of Peripheral Interventional Devices in the OPEQ; and Dr. Maisel is Director of OPEQ.

The authors’ survey includes a review of the interim analysis of the SWEDEPAD trial, which found no significant mortality difference in PCDs versus uncoated endovascular devices during 1 to 4 years of follow-up. Joakim Nordanstig, MD, et al published the SWEDEPAD analysis findings in NEJM on December 9, 2020.

In the NEJM Perspectives article, Dr. Farb et al stated, “The results of the SWEDEPAD interim analysis provide important and reassuring information on PCDs used to treat femoropopliteal disease. Furthermore, recent analyses of additional data from nonrandomized studies have not identified an increased mortality risk associated with PCDs.” However, the authors cautioned, “These newer analyses, though comforting, are limited by the duration of follow-up.”

The authors further noted, “Because of the demonstrated short-term benefits of the devices and the limitations of the available data, the FDA believes that clinical studies of these devices should continue and should collect long-term mortality data. Similarly, the FDA now routinely reviews longer-term data for PCDs for which market authorization is being sought when they are intended to treat patients with PAD, and the agency requests that trials capture information on adjunctive antithrombotic therapy and medications indicated for patients with atherosclerosis.”

“The FDA will continue to work with investigators, medical professional societies, and the device industry to facilitate data development and to communicate with the public as new information becomes available,” advised Dr. Farb et al.

In October 2020, the Multi-Specialty and Multi-Society Coalition for Patient Safety with Paclitaxel Technologies issued a set of talking points for informing patients about the risks and benefits of PCDs in the treatment of PAD. The FDA tasked the coalition with developing these talking points, which are the result of discussions across specialties.

In August 2019, the FDA issued an updated statement (online here) on the increased mortality potentially associated with the use of PCDs for the treatment of PAD.

In the present NEJM commentary, the FDA authors reiterated the following:

• PAD patients should receive the best available medical therapy and guidance to promote healthy lifestyles, including weight control, smoking cessation, and exercise.
• For patients requiring further treatment to relieve symptoms, PCDs improve blood flow to the legs and are more likely than uncoated devices to avert the need for repeat procedures to reopen blocked blood vessels.
• The benefits and risks associated with available PAD treatment options should be carefully considered and discussed with individual patients.
• The use of a PCD may be the best treatment for some patients, particularly those judged to be at particularly high risk for restenosis and repeat femoropopliteal interventions.
• Additional data are needed to further refine optimal treatment strategies for patients on the basis of their risk profile for restenosis, incorporating patient-specific factors (eg, presence of diabetes, endothelial dysfunction, increased platelet activity, or systemic inflammation) and lesion-specific factors (eg, small-diameter vessels, long lesions, high plaque burden, or reduced distal runoff).